Specification, Implementation, Management and Execution of Clinical Test Ordering Protocols: a Datab

1
Specification, Implementation, Management and
Execution of Clinical Test Ordering Protocols
a Database Approach (Kudakwashe Dube and Bing
Wu)

• Presented by Dr Bing Wu
• Computer Science Department
• Dublin Institute of Technology, Ireland

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Outline of the Presentation

• Introduction
• Project Background and Aim
• Problem Domain
• Some Related Work
• Enabling Technology
• Event-Condition-Action (ECA) Mechanism
• Discussion
• A Model of Test Ordering Protocols
• PLAN a specification language
• Example Test Ordering Protocol
• Storage of Protocol Specifications
• Management Operations and Workflow
• Implementation Architecture
• Dynamic Execution Scenario
• Summary
• Future Work

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Project Background

• Computerized Clinical Test Ordering Protocols can
  help.
• Such computerized protocols must be manageable in
  a full scale.
• The instantiated test ordering plan from a
  generic test ordering protocol for an individual
  patient must also be manageable in a full scale.

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Project Aim

• To develop, within an integrated healthcare
  environment, a database system which enables the
• Specification,
• Storage,
• Execution,
• Querying,
• Manipulation
• of the clinical test ordering protocols.

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Problem Domain

Clinical Test protocols
Patient Demographic Information
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Enabling Technology

EHCR
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Some Related Work

• Diagnostic and Therapy Guidelines and Protocols
• DILEMMA (Thompson et al, 1995)
• EON (Musen et al, 1996)
• PROforma (Fox et al, 1996)
• GLIF (Ohno-Machado et al, 1998)
• Asgaard/Asbru (Shahar et al, 1998 Miksch, 1999)
• Supporting guidelines and protocols in the
  clinical test ordering domain
• Peters et al, 1991
• Lepage et al, 1992 Overhage et al, 1997
  Kuperman et al, 1999
• BloodLink (van Wijk et al, 1999)

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Some Related Work

• Our approach differs from others ...
• takes a database and ECA rule approach
• places emphasis on issues of storing, executing,
  querying and manipulating of specified protocols
  
• draws a clear line between the static test
  request protocols and the dynamic patient test
  plans.
• allows not only higher lever management of
  generic test request protocols, but also lower
  lever management of test plans for individual
  patients

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Event-Condition-Action (ECA) Mechanism

• ON event IF condition THEN action

condition
ignore (false)
execute (true)
check
event
action
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ECA Rule in the Test Ordering Domain

• WHEN
• a relevant clinical event occurs
• IF
• the test ordering condition is satisfied
• THEN
• a clinical test is ordered

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Test Ordering Protocol Model

EXECUTION
SPECIFICATION
INSTANTITION
Global Rule
Patient Category
Test Ordering Protocol
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PLAN Language for Specifying Test Ordering
Protocols
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Example Test Ordering Protocol
A test protocol for a LIVER TRANSPLANT patient
category (Peters et al, 1991).
Day 0 day after that entered in Class/Category
'LIVER TRANSPLANT'
Fence post rules (Static rule)
Do UE tests on days -1,0,1,2,3,4,6,8,11(3)
Do
LFTs
, PT, FBC tests on days -1(1), 14(3)
Do CYA test on days 0(1) unless on FK trial
Do MG test on days 0,7,14
HB,FBC,PT on days -1(1),14(3)
Do Serum BANK on days 7(7)
Protocol Rules
Do UE tests on same day
If K gt 5.5 or K lt 3
Do UE tests on day1
If K gt5.1 or K lt 3.4 or delta gt0.4
if(UR gt 10 and day lt 9) or UR gt 20 or delta gt 4
if (day lt 9 and CREAT gt 110) or (CREAT gt 210) or
delta gt 25
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Example Test Ordering Protocol
Protocol for viral hepatitis testing (British
Columbia Medical Association, Canada)
Patient Age gt 15 months
Overall precondition
HAV, HBV, HCV,
Tests covered
Acute Viral Hepatitis
Test anti-HAV
IgM
Further tests are subject to the following logic
If POSITIVE then STOP
Else per
form test
HbsAg
If
HbsAg result is POSITIVE then (further tests
only on request)
Else perform test anti-HCV
Immunity to HAV
Test anti-HAV
Hepatitis B Carrier
Test
HbsAg
Investigating a patient with Previous or Chronic
Hepatitis
(E.g. investigation of elevated AST and/or ALT)
Tests
1.

anti-
HBc
HBs and anti-HCV
2.

If anti-
HBc result is POSITIVE then perform anti-
Else STOP
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Example Test Protocol in PLAN
PROTOCOL Viral-Heptitis-Testing DESIGNER Dr
Egan DESIGN-DATE 14/6/2000 DESIGN-TIME
1200 AUTHORISER Dr OReilly AUTHORISED-DATE
15/06/2000 AUTHORISED-TIME 1400
Protocol Header
CASE Acute-vital-Hepatitis BASE-SCHEDULES
Acute-Viral-Hepatitis BEGIN BASE-SCHEDULES STATI
C-RULE sr1 DESIGNER-NAMEDr Egan DESIGN-DATE14
/06/2000 Rule-TYPEstaticactive BEGIN-STATIC-RU
LE ZERO-TIMEPOINTconsulation-day ON DAY SAME
DO anti-HAV-IgM END-STATIC-RULE. END-BASE-SCHEDUL
E
A Base Schedule for a case of suspected Acute
Viral Hepatitis
PROTOCOL-RULE pr1 DESIGNER-NAME Dr
EGAN DESIGN-DATE 14/06/2000 DESIGN-TIME
1200 RULE-TYPE protocol RULE-STATUS
inactive BEGIN-PROTOCOL-RULE ON RESULT
anti-HAV-IgM IF POSITIVE anti-HAV-IgM DO STOP
PROTOCOL END-PROTOCOL-RULE
A protocol Rule for anti-HAV lam applicable to
entire protocol
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Example Test Protocol in PLAN
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Storage of Protocol Specifications
Specification Plane and Execution Plane
Relational Database
PLAN Protocol Specifications
Protocols for Categories
Test Plan for a Patient
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Protocol Management Operations
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Test Protocol Management Flow
Logical
Physical
Conceptual
Specification
Test Ordering Protocol
Protocol Specification
Protocol Specification Database
Execution
Patient Test Plan
Test Plan Specification
Execution (ECA Rules)
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Management Workflow
Specification
Phase
Category
protocol specification
Customisation
Patient Clinical
Management
Phase
Data
(querying
Patient test
modification)
ordering plan
Installation
Phase
Instantiated patient
test plan
Execution
Phase
Test Results
Test orders, alerts,
alarms, etc
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Implementation Architecture

EHCR Server
Patient Category Manager
External Communicator
User
Test Ordering Protocol Manager
OCS/LIS
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Dynamic Execution Scenario

OCS/ LIS
test order
Test Plan
notify
user
manage plan rules
manage protocol
Stored Procedure
On INSERT
Test Protocols
test result
Patient Test Plan (Rules)
Patient Data
execute
Database System
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Protocol Management Scenario
PROTOCOL MODEL
REAL WORLD
Static changes
specification
Protocol
Protocol
Authoring
Specification
Continuous
customization
Modifications
Change
random changes
propagation
adjustments
Patient-clinician
Protocol
Encounter/
Instance
Interaction
Combined planning execution
Dynamic changes
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Current Future Work

• Current
• implementation of a prototype system with Oracle.
• Possible Future Work
• further development of the modelling framework of
  test request protocols (e.g. version,
  multi-inheritance, category-transfer),
• further development of PLAN language,
• evaluation of prototype implementation,
• deployment of a practical system into a
  heterogeneous system with the integration of EHCR,

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Summary

EHCR
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Specification, Implementation, Management and
Execution of Clinical Test Ordering Protocols a
Database Approach (Kudakwashe Dube and Bing Wu)

• Thanks for Your Attention!

Any Questions?
Presented by Dr Bing Wu Computer Science
Department Dublin Institute of Technology,
Ireland
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Background Clinical Test Ordering Domain
Problem increasing costs of clinical laboratory
usage (Grossman, 1983 van Walraven et al,
1998) Solution initiatives feedback,
education, cost awareness, incentives, penalties,
rationing (Grossman, 1983 Einsenberg, 1985
Peters et al, 1993) Generally agreed effective
solution test ordering protocols (Grimshaw et
al, 1993, Boran et al, 1994 OMoore et al,1996
Solomon et al, 1999 van Wijk et al,
1999) Benefits from computer-based test ordering
protocols reduced unnecessary test orders
(Boran et al, 1994 OMoore et al,1996
Solomon et al, 1999 van Wijk et al, 1999)
reduction of sample collections through sample or
result re-use (McNeely et al, 1995) reduction
of turn-around time to diagnosis (Smith et al
1999)